Long-term outcomes of abatacept in individuals at risk of developing rheumatoid arthritis (APIPPRA Long-Term Outcome (ALTO)): a randomised, double-blind, placebo-controlled trial
Primary result · Restricted mean arthritis-free survival time (time to clinical synovitis in ≥3 joints, RA by ACR-EULAR 2010 criteria, or first DMARD)Result — go to the resultDifference in restricted mean arthritis-free survival time 4.9 months 95% CI 0.1–9.6Authors' conclusion
In this at-risk population, 1-year treatment with abatacept delayed progression to rheumatoid arthritis for up to 4 years. Those at highest risk of progression have a broad autoantibody profile but are more responsive to abatacept treatment.
Study context
- Population
- Anti-citrullinated protein antibody (ACPA)-positive individuals with arthralgia, 28 hospital-based early arthritis clinics in the UK and three in the Netherlandsof 213 APIPPRA participants
- Participants
- 143 individuals
- Comparison
- Abatacept 125 mg SC weekly for 52 weeks vs placebo
- Abataceptn = 71
- Placebon = 72reference
- Primary endpoint
- Time from randomisation to clinical synovitis in ≥3 joints, RA by ACR-EULAR 2010 criteria, or first DMARD treatment, whichever first
Methodological detailsphase 2b, double-blind, placebo-controlled, multicentre, Participants and clinical assessors remained masked; follow-up extended to between 4 and 8 years
- Phase 2b
- Double-blind
- Placebo-controlled
- Multicentre
- Participants and clinical assessors remained masked; follow-up extended to between 4 and 8 years
Primary result
As reported in the abstract
Restricted mean arthritis-free survival time (time to clinical synovitis in ≥3 joints, RA by ACR-EULAR 2010 criteria, or first DMARD) · up to 4 years
Difference in restricted mean arthritis-free survival time
4.9 months
95% CI 0.1–9.6
P = 0.044
Abatacept 125 mg SC weekly for 52 weeksvs placebo
difference in restricted mean arthritis-free survival time 4.9 months (95% CI 0.1–9.6); P = 0.044
Further findings
Disease activity and patient reported outcomes beyond the treatment period
- No significant differences between groups
Primary outcome by baseline autoantibody profile (subgroup)
- Broad autoantibody profile at highest risk of progressing but responded better to abatacept
Safety
Events
| Outcome | Abatacept | Placebo |
|---|---|---|
| Serious adverse eventsNone deemed related to study drug | 18 | 13 |
Original publication
Long-term outcomes of abatacept in individuals at risk of developing rheumatoid arthritis (ALTO): a randomised, double-blind, placebo-controlled trial. Lancet Rheumatol. Published 20 January 2026. doi:10.
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